Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to give their full, informed agreement to participate and follow all study requirements
• People diagnosed with Stage III non-small cell lung cancer (NSCLC) who received standard chemotherapy combined with radiation, followed by a drug called durvalumab, and whose cancer either grew again (progressed) or did not fully go away (persistent disease confirmed by scan and biopsy at least 6 months after finishing initial treatment)
• People with a type of lung cancer called adenocarcinoma who do not have certain specific genetic changes in their tumour (such as EGFR mutations, ALK fusions, ROS1 rearrangements, RET fusions, or MET exon 14 changes) for which other standard treatments exist — genetic testing must be completed before treatment begins (confirm with trial site)
• People whose cancer has come back in 3 or fewer spots (Cohort A — called "oligoprogressive disease"), where multiple affected lymph node areas in the chest count as one spot
• People whose cancer has come back in more than 3 spots (Cohort B — called "polyprogressive disease"), where multiple affected lymph node areas in the chest count as one spot
• People for whom radiation therapy to at least one tumour is considered appropriate by their treating team
• People who have had tumour scans (CT scan with contrast of chest, abdomen, and pelvis, or PET-CT) and a brain MRI within the 28 days before joining the study
• People aged 18 or older at the time of joining the study
• People who have a good general level of physical functioning, rated 0 or 1 on a standard scale used in cancer care (meaning fully active or restricted in physically strenuous activity but able to carry out light work) (confirm with trial site)
• People who weigh more than 30 kg
• People whose blood counts and organ function meet specific levels set by the trial, including haemoglobin, platelets, liver enzymes, bilirubin, and kidney function (confirm with trial site for exact values)
• People who are willing and able to attend all required study visits and follow all study procedures for the full duration
• People with a life expectancy of at least 12 weeks

Who may not be able to join:

• People whose cancer grew very quickly while on durvalumab — specifically, people whose cancer showed progression on the first 3-month scan after starting durvalumab following chemoradiation
• People who previously received a different type of immunotherapy drug (anti-PD-(L)1 therapy) other than durvalumab
• People who have taken part in another clinical trial involving an experimental treatment within the last 4 weeks, or who are currently enrolled in another treatment-based clinical trial
• People who received any other anti-cancer treatment within 28 days before the first study dose (this waiting period does not apply to durvalumab)
• People who still have unresolved side effects of grade 2 or higher from previous cancer treatment (with some exceptions such as hair loss or certain stable conditions — confirm with trial site)
• People currently receiving other chemotherapy, experimental drugs, biological therapies, or hormonal cancer treatments at the same time (hormonal therapy for non-cancer conditions such as menopause is allowed)
• People who have had a major surgical procedure within 28 days before starting the study drug
• People who have had an organ transplant from another person
• People with active or previously documented autoimmune or inflammatory conditions such as inflammatory bowel disease, lupus, rheumatoid arthritis, or similar disorders (some exceptions apply — confirm with trial site)
• People with poorly controlled or serious ongoing illnesses, including active infections, severe heart conditions, uncontrolled high blood pressure, lung inflammation, serious ongoing gut conditions, or significant mental health or social circumstances that would make participation unsafe or difficult
• People with a history of another cancer, unless it was treated with the aim of cure, has shown no signs of returning for at least 3 years, and carries a low risk of coming back (some skin cancers and carcinoma in situ that have been fully treated may be acceptable — confirm with trial site)
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord
• People with brain metastases that have not yet been treated, or that have been treated but have not been shown to be stable on two brain scans taken at least four weeks apart — treated brain metastases must also not be causing ongoing neurological symptoms, or any such symptoms must be stable and managed with low-dose steroids (10 mg per day of prednisone or equivalent or less) and/or seizure medication for at least 14 days before starting treatment
• People with a specific type of heart rhythm abnormality detected on an ECG (a QTcF interval of 470 ms or more) (confirm with trial site)
• People with a history of a primary immune deficiency condition
• People with active tuberculosis, active hepatitis B, or active hepatitis C infection (confirm with trial site for specific testing requirements)
• People who have used immune-suppressing medications within 14 days before the first dose of durvalumab, with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions (confirm with trial site)
• People who have received a live vaccine within 30 days before starting the study drug
• People who are pregnant or breastfeeding, or people of reproductive age who are not willing to use effective contraception from the start of the study until 90 days after the last dose of durvalumab
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People who previously stopped immunotherapy permanently due to serious side effects, or who experienced serious immune-related side effects (grade 3 or higher, or any grade affecting the nervous system or eyes) during prior immunotherapy
• People who required treatments beyond corticosteroids to manage immunotherapy side effects, or who currently need more than 10 mg per day of prednisone (or equivalent) on an ongoing basis
• People whom the trial investigator considers unsuitable to participate or unlikely to follow all study requirements

Important: Always verify eligibility with the trial site directly before applying.